Antara (fenofibrate) Capsules, is a lipid regulating agent available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate.
Primary Hypercholesterolemia and Mixed Dyslipidemia
Antara is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.
Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (eg, > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. [ see Warnings and Precautions (5.1)].
Published Studies Related to Antara (Fenofibrate)
Paradoxical reduction in HDL-C with fenofibrate and thiazolidinedione therapy in
type 2 diabetes: the ACCORD Lipid Trial. 
CONCLUSIONS: Idiosyncratic and marked reduction in HDL-C can occur in some
Long-term safety and efficacy of fenofibrate/pravastatin combination therapy in high risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy. [2011.11]
OBJECTIVE: To assess the long-term safety and efficacy of a fenofibrate/pravastatin 160/40 mg fixed-dose combination in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy... CONCLUSIONS: Long-term co-administration of fenofibrate/pravastatin 160/40 mg in a single capsule was well tolerated and produced complementary benefits on the overall lipid profile of high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg.
Fenofibrate: a review of its lipid-modifying effects in dyslipidemia and its vascular effects in type 2 diabetes mellitus. [2011.08.01]
Fenofibrate is a fibric acid derivative with lipid-modifying effects that are mediated by the activation of peroxisome proliferator-activated receptor-alpha... In conclusion, monotherapy with fenofibrate remains a useful option in patients with dyslipidemia, particularly in atherogenic dyslipidemia characterized by high TG and low HDL-C levels.
Combination of niacin and fenofibrate with lifestyle changes improves dyslipidemia and hypoadiponectinemia in HIV patients on antiretroviral therapy: results of "heart positive," a randomized, controlled trial. [2011.07]
CONTEXT: HIV patients on antiretroviral therapy (ART) have a unique dyslipidemia [elevated triglycerides and non-high-density lipoprotein-cholesterol (HDL-C), low HDL-C] with insulin resistance (characterized by hypoadiponectinemia). OBJECTIVE: The aim was to test a targeted, comprehensive, additive approach to treating the dyslipidemia... CONCLUSIONS: A combination of fenofibrate and niacin with low-saturated-fat D/E is effective and safe in increasing HDL-C, decreasing non-HDL-C and hypertriglyceridemia, and ameliorating hypoadiponectinemia in patients with HIV/ART-associated dyslipidemia.
Single-dose bioequivalence of 105-mg fenofibric acid tablets versus 145-mg fenofibrate tablets under fasting and fed conditions: a report of two phase I, open-label, single-dose, randomized, crossover clinical trials. [2011.06]
BACKGROUND: Fenofibrate is used to treat primary hypercholesterolemia, mixed lipidemia, and hypertriglyceridemia in adults who do not respond to nonpharmacologic measures. Fenofibrate is a prodrug that is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. A new orally administered agent, fenofibric acid, was developed as an alternative to fenofibrate. OBJECTIVE: Two separate studies were conducted to evaluate the bioequivalence of fenofibric acid relative to fenofibrate under fasted and fed (standard breakfast) conditions, characterize the pharmacokinetic profile, and assess the safety and tolerability of fenofibric acid... CONCLUSIONS: In these 2 single-dose studies, these healthy volunteers administered a single oral dose of 105-mg fenofibric acid met the US Food and Drug Administration regulatory criteria for assuming bioequivalence to a single oral dose of 145-mg fenofibrate tablets with respect to the rate and extent of fenofibric acid absorption in both fed and fasted states. Fenofibric acid at the dose studied was well tolerated in this population. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.
Clinical Trials Related to Antara (Fenofibrate)
Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension [Completed]
The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid
ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of
patients with very high triglycerides.
The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of
adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects
treated with fenofibrate in lowering serum triglyceride (TG) levels.
Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL) [Terminated]
The design of the study will be randomized, double blind trial, which will examine the
effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL),
low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and
C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic
effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will
help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein
concentrations through improving insulin sensitivity and glycemic control, or by directly
influencing the synthesis of the apolipoproteins that are responsible for very-low-density
lipoprotein (VLDL) and HDL metabolism.
Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease [Completed]
Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and
decreasing triglyceride levels. The interaction with these receptors has antiatherogenic
actions by regulating the expression con key proteins that participate in vascular
inflammation, plaque stability and thrombosis.
Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small,
dense LDL particles. The use of this drug has resulted in improvement of vascular function
measured by endothelial function. Our hypotheses state that fenofibrate will improve:
endothelial function, improve HDL antioxidant capacity and size distribution towards a
predominance of small HDL particles.
Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate) [Completed]
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to
145 mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary
objective is to characterize the pharmacokinetic profile of fenofibric acid when
administered as a single 105 mg dose to healthy volunteers in a fasted state. Safety and
tolerability of this regimen will also be evaluated.
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic [Completed]
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk
equivalents, whose TG level is not adequately controlled after statin monotherapy. According
to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient
who has insufficient improvement. The purpose of the study is to evaluate the efficacy on
lipid control and the safety of adding fenofibrate in patients on a background of statin
Page last updated: 2014-11-30